NCT01819649

Brief Summary

This is a pilot study proceeding an intended international trial. Hypothesis: Daily intake of selenium supplementation in the form of selenium-enriched yeast tablets will reduce the risk of cancer in healthy individuals. Objective: The objective of this pilot study was to assess the viability of a full scale randomised trial. AMENDMENT TO STUDY OBJECTIVE: Mortality analysis during intervention and follow-up as specified in the sections concerning study design and outcome measures.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
491

participants targeted

Target at P75+ for not_applicable cancer

Timeline
Completed

Started Nov 1998

Longer than P75 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 1998

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
8.7 years until next milestone

First Submitted

Initial submission to the registry

January 23, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 27, 2013

Completed
Last Updated

September 14, 2017

Status Verified

September 1, 2017

Enrollment Period

5.6 years

First QC Date

January 23, 2013

Last Update Submit

September 13, 2017

Conditions

Cancer

Keywords

seleniumselenium supplementationrandomised controlled trialprevention

Outcome Measures

Primary Outcomes (1)

  • Viability of full scale study

    At five years intervention (last participant last visit was june 2004) viability of full scale study was assessed according to the drop out rate, cost etc. of this pilot study.

    At five years intervention

Secondary Outcomes (1)

  • AMENDMENT TO OUTCOME MEASURES: Mortality analysis.

    Up to 17 years

Study Arms (4)

Selenium enriched-yeast tablet; SelenoPRECISE 100 mcg/d

EXPERIMENTAL
Dietary Supplement: SelenoPRECISE selenium-enriched yeast tablet, Pharma Nord Denmark A/S

Selenium enriched-yeast tablet; SelenoPRECISE 200 mcg/d

EXPERIMENTAL
Dietary Supplement: SelenoPRECISE selenium-enriched yeast tablet, Pharma Nord Denmark A/S

Selenium enriched-yeast tablet; SelenoPRECISE 300 mcg/d

EXPERIMENTAL
Dietary Supplement: SelenoPRECISE selenium-enriched yeast tablet, Pharma Nord Denmark A/S

Yeast tablet

PLACEBO COMPARATOR
Dietary Supplement: SelenoPRECISE selenium-enriched yeast tablet, Pharma Nord Denmark A/S

Interventions

SelenoPRECISE selenium-enriched yeast tablet, Pharma Nord Denmark A/SDIETARY_SUPPLEMENT
Selenium enriched-yeast tablet; SelenoPRECISE 100 mcg/dSelenium enriched-yeast tablet; SelenoPRECISE 200 mcg/dSelenium enriched-yeast tablet; SelenoPRECISE 300 mcg/dYeast tablet

Eligibility Criteria

Age60 Years - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • WHO performance status 0 or 1
  • No active liver- or kidney disease (Serum ALAT (alanine aminotransferase), alkalic phosphatase, bilirubin, creatinin or urea within 2 S.D of laboratory reference range)
  • No previous cancer diagnosis
  • No known HIV-infection
  • Participant must understand oral and written information
  • Participant must not use selenium supplementation of above 50 mcg/d

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Selenium Centre, Odense University Hospital

Odense C, 5000, Denmark

Location

Related Publications (1)

  • Cold F, Winther KH, Pastor-Barriuso R, Rayman MP, Guallar E, Nybo M, Griffin BA, Stranges S, Cold S. Randomised controlled trial of the effect of long-term selenium supplementation on plasma cholesterol in an elderly Danish population. Br J Nutr. 2015 Dec 14;114(11):1807-18. doi: 10.1017/S0007114515003499. Epub 2015 Sep 30.

    PMID: 26420334DERIVED

MeSH Terms

Conditions

Neoplasms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: AMENDMENT TO STUDY DESIGN: Towards the end of the intervention period, it was decided to follow-up participants for an additional ten years via Danish public registries for data on morbidity and mortality.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D. PhD

Study Record Dates

First Submitted

January 23, 2013

First Posted

March 27, 2013

Study Start

November 1, 1998

Primary Completion

June 1, 2004

Study Completion

June 1, 2004

Last Updated

September 14, 2017

Record last verified: 2017-09

Locations

DK(1)